Development of Novel MRI Methods for Detecting, Discriminating, and Measuring Liver Fibrosis and Congestion in Fontan Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- MR elastography data correlation to histologic data
Study Overview
Brief Summary
In this research study, the investigators will conduct a prospective cross-sectional study of pediatric and adult Fontan patients that will correlate a variety of quantitative MRI biomarkers with histopathologic data.
Detailed Description
The purpose of this study is to develop noninvasive MRI methods for detecting, discriminating, and measuring liver fibrosis and congestion in the adolescent and adult Fontan population by correlating quantitative imaging measurements with histopathologic data, using a cross-sectional approach.
Over 5 years, approximately 40 pediatric and adult subjects (approximately 8 subjects per year) undergoing clinically-indicated liver biopsy for the evaluation of either 1) focal liver lesions/masses, or 2) suspected liver fibrosis/parenchymal disease will be recruited to participate in this study. Subjects will undergo research MR imaging within ±2 weeks of the liver biopsy procedure. A variety of MRI biomarkers will be correlated with histopathologic data obtained from the clinically indicated liver biopsy.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 8 Years to 99 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Single ventricle physiology congenital heart disease status post Fontan palliation
- •Undergoing clinically-indicated liver biopsy
- •Ability to tolerate 60 minutes in an MRI scanner without sedation
Exclusion Criteria
- •Known contraindication to MR imaging (e.g., implanted non-MRI compatible device)
- •Known or suspected pregnancy. Female subjects of child bearing potential will undergo urine pregnancy testing prior to imaging
Outcomes
Primary Outcomes
MR elastography data correlation to histologic data
Time Frame: 60 minutes
MR elastography of the liver data will be correlated with histopathologic data obtained from non-lesional liver tissue. Histologic fibrosis and congestion will be scored by a pathologist using semi-quantitative grading systems (e.g., METAVIR scoring system for fibrosis
Secondary Outcomes
- MR T1rho data correlation to histologic data(60 minutes)
- MR T1 mapping data (corrected and uncorrected) correlation to histologic data(60 minutes)
- MR T2 mapping data correlation to histologic data(60 minutes)
- MR Diffusion weighted data correlation to histologic data(60 minutes)